Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, lot numbers 44134-01 and 43589-01; the breather pouch measures 25.25 inches x 30.75 inches, 5 mil thick; Medline Industries, Inc., Mundelein, IL 60060;
This recall has been terminated (originally issued March 11, 2005).
- Company
- Medline Industries, Inc.
- Recall Initiated
- March 4, 2005
- Posted
- March 11, 2005
- Terminated
- May 25, 2006
- Recall Number
- Z-0554-05
- Quantity
- 31,497 cases
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for open side seals post-sterilization of the Tyvek breather pouches used in the custom sterile packs.
Distribution
Nationwide
Lot / Code Info
all lots distributed between 6/15/04 and 3/1/05 of the following reorder numbers: DYNJ02170A, DYNJ02176A, DYNJ02179B, DYNJ02182A, DYNJ04314A, DYNJ04316, DYNJ04321, DYNJ04325, DYNJ04329, DYNJ04336B, DYNJ04338B, DYNJ04371, DYNJ04383, DYNJ04388, DYNJ04407A, DYNJ04408A, DYNJ04419A, DYNJ04427, DYNJ04455, DYNJ04468B, DYNJ04472A, DYNJ04476, DYNJ04478A, DYNJ04481B, DYNJ04482, DYNJ04483, DYNJ04485, DYNJ04494, DYNJ04497, DYNJ04502, DYNJ04504, DYNJ04505, DYNJ04509, DYNJ04542, DYNJ04545, DYNJ04548A, DYNJ04556A, DYNJ04557B, DYNJ04558A, DYNJ04572, DYNJ04579A, DYNJ04597, DYNJ04609, DYNJ04611A, DYNJ04620A, DYNJ04629B, DYNJ04676A, DYNJ04677, DYNJ04683, DYNJ04691, DYNJ04709A, DYNJ04710, DYNJ04711, DYNJ04711A, DYNJ04712, DYNJ04713A, DYNJ04720A, DYNJ04723, DYNJ04729, DYNJ04744, DYNJ04745A, DYNJ04754A, DYNJ04805A, DYNJ04807A, DYNJ04811, DYNJ04822A, DYNJ04825A, DYNJ04832, DYNJ04834, DYNJ04840, DYNJ04841, DYNJ04878, DYNJ04880, DYNJ04888, DYNJ05787K, DYNJ05798K, DYNJ06075G, DYNJ06324L, DYNJ06682B, DYNJ06739B, DYNJ06743A, DYNJ06744B, DYNJ06782A, DYNJ06796J, DYNJ06839A, DYNJ06873A, DYNJ06876D, DYNJ06876F, DYNJ06908B, DYNJ06927A, DYNJ06930F, DYNJ06952F, DYNJ06976, DYNJ07536, DYNJ07537C, DYNJ07626A, DYNJ07626A, DYNJ07626A, DYNJ07670C, DYNJ07833F, DYNJ07881C, DYNJ07910A, DYNJ07942, DYNJ07942, DYNJ07951A, DYNJ07954A, DYNJ07954A, DYNJ07982A, DYNJ07995, DYNJ08351K, DYNJ08387F, DYNJ08601A, DYNJ08671I, DYNJ08713C, DYNJ08796D, DYNJ08802, DYNJ08814F, DYNJ08815D, DYNJ08816C, DYNJ08840J, DYNJ08844I, DYNJ09066C, DYNJ09156F, DYNJ09174D, DYNJ09188A, DYNJ09194F, DYNJ09258R, DYNJ09259I, DYNJ09261J, DYNJ09294B, DYNJ09322D, DYNJ09343F, DYNJ09346, DYNJ09397A, DYNJ09398, DYNJ09449C, DYNJ09515C, DYNJ09528D, DYNJ09531D, DYNJ09532F, DYNJ09533F, DYNJ09590D, DYNJ09617B, DYNJ09619D, DYNJ09624A, DYNJ09677A, DYNJ09677C, DYNJ09681C, DYNJ09682B, DYNJ09684B, DYNJ09694A, DYNJ09703B, DYNJ09787B, DYNJ09807K, DYNJ09857B, DYNJ09858A, DYNJ09874C, DYNJ09875G, DYNJ09882A, DYNJ09921, DYNJ09923, DYNJ09932B, DYNJ09933, DYNJ09941C, DYNJ09981A, DYNJ14000A, DYNJ14002, DYNJ14005A, DYNJ14006, DYNJ14008A, DYNJ14014, DYNJ14017A, DYNJ14018A, DYNJ14024, DYNJ14038, DYNJ14039, DYNJ14069A, DYNJ14078A, DYNJ14079, DYNJ14095A, DYNJ14096B, DYNJ14097, DYNJ14107, DYNJ14107, DYNJ14110, DYNJ14112A, DYNJ14114, DYNJ14119, DYNJ14127, DYNJ14130, DYNJ14134, DYNJ14137, DYNJ14147A, DYNJ14148A, DYNJ14149A, DYNJ14150A, DYNJ14156B, DYNJ14157B, DYNJ14170, DYNJ14187, DYNJ14218A, DYNJ14225A, DYNJ15062, DYNJ15332A, DYNJ15392D, DYNJ15393G, DYNJ15428F, DYNJ15455P, DYNJ15494A, DYNJ15504D, DYNJ15519A, DYNJ15615D, DYNJ15643L, DYNJ15660C, DYNJ15660D, DYNJ15668D, DYNJ15703A, DYNJ15751C, DYNJ15752, DYNJ15814I, DYNJ15903C, DYNJ15956B, DYNJ15980A, DYNJ16018F, DYNJ16025B, DYNJ16026B, DYNJ16065A, DYNJ16072D, DYNJ16076I, DYNJ16079B, DYNJ16082B, DYNJ16114F, DYNJ16127C, DYNJ16131B, DYNJ16206A, DYNJ16250C, DYNJ16263C, DYNJ16274B, DYNJ16280B, DYNJ16284, DYNJ16289B, DYNJ16327C, DYNJ16327D, DYNJ16342, DYNJ16346A, DYNJ16350C, DYNJ16376C, DYNJ16379B, DYNJ16381C, DYNJ16384, DYNJ16435, DYNJ16461C, DYNJ16510D, DYNJ16514B, DYNJ16518A, DYNJ16535A, DYNJ16536A, DYNJ16541B, DYNJ16567C, DYNJ16575, DYNJ16577, DYNJ16589, DYNJ16591, DYNJ16604, DYNJ16604A, DYNJ16623, DYNJ16625, DYNJ16644, DYNJ17003A, DYNJ17008, DYNJ17016A, DYNJ17018, DYNJ17020, DYNJ17042, DYNJ17044, DYNJ17045A, DYNJ17053, DYNJ17065, DYNJ17068, DYNJ17082, DYNJ19022D, DYNJ19023C, DYNJ19029A, DYNJ19051B, DYNJ19061D, DYNJ19069B, DYNJ19073B, DYNJ19081D, DYNJ19109A, DYNJ19121, DYNJ19138C, DYNJ19139A, DYNJ19146C, DYNJ19146D, DYNJ19154B, DYNJ19170B, DYNJ19199A, DYNJ19230D, DYNJ19233B, DYNJ19234B, DYNJ19235A, DYNJ19249B, DYNJ19251A, DYNJ19256B, DYNJ19257A, DYNJ19296C, DYNJ19329C, DYNJ19371, DYNJ19390B, DYNJ19395B, DYNJ19416B, DYNJ19418D, DYNJ19419A, DYNJ19419B, DYNJ19441D, DYNJ19451I, DYNJ19461B, DYNJ19468A, DYNJ19469, DYNJ19479A, DYNJ19483, DYNJ19500A, DYNJ19501B, DYNJ19509C, DYNJ19515, DYNJ19527D, DYNJ19529A, DYNJ19550A, DYNJ19551B, DYNJ19564A, DYNJ19589A, DYNJ19590A, DYNJ19603B, DYNJ19611B, DYNJ19612B, DYNJ19620A, DYNJ19637G, DYNJ19638F, DYNJ19646D, DYNJ19655A, DYNJ19657, DYNJ19674B, DYNJ19675D, DYNJ19679D, DYNJ19684A, DYNJ19686, DYNJ19694A, DYNJ19696A, DYNJ19697A, DYNJ19699A, DYNJ19709C, DYNJ19710B, DYNJ19724A, DYNJ19726A, DYNJ19729A, DYNJ19730B, DYNJ19738, DYNJ19771B, DYNJ19775A, DYNJ19777A, DYNJ19777A, DYNJ19787B, DYNJ19788A, DYNJ19789A, DYNJ19790B, DYNJ19791D, DYNJ19804B, DYNJ19813, DYNJ19814A, DYNJ19816A, DYNJ19830, DYNJ19833, DYNJ19842A, DYNJ19850B, DYNJ19853, DYNJ19880B, DYNJ19882B, DYNJ19885B, DYNJ19887B, DYNJ19888, DYNJ19900C, DYNJ19901D, DYNJ19907, DYNJ19910, DYNJ19918B, DYNJ19919B, DYNJ19923, DYNJ19929A, DYNJ19929B, DYNJ19933G, DYNJ19935F, DYNJ19938, DYNJ19944, DYNJ19949A, DYNJ19951B, DYNJ19953A, DYNJ19955A, DYNJ19960B, DYNJ19964B, DYNJ19981A, DYNJ19997F, DYNJ20004F, DYNJ20007C, DYNJ20010A, DYNJ20012A, DYNJ20013A, DYNJ20020A, DYNJ20021A, DYNJ20026A, DYNJ20027A, DYNJ20028A, DYNJ20029, DYNJ20030B, DYNJ20031, DYNJ20034, DYNJ20040A, DYNJ20053B, DYNJ20055A, DYNJ20079A, DYNJ20081A, DYNJ20084, DYNJ20104, DYNJ20106A, DYNJ20107, DYNJ20114C, DYNJ20115, DYNJ20117, DYNJ20124A, DYNJ20125, DYNJ20126A, DYNJ20127A, DYNJ20134B, DYNJ20135C, DYNJ20137A, DYNJ20138B, DYNJ20142A, DYNJ20151B, DYNJ20169, DYNJ20170, DYNJ20181, DYNJ20185, DYNJ20186, DYNJ20187A, DYNJ20198A, DYNJ20200, DYNJ20202A, DYNJ20208, DYNJ20211A, DYNJ20213A, DYNJ20214A, DYNJ20215A, DYNJ20216, DYNJ20218A, DYNJ20221A, DYNJ20230, DYNJ20232, DYNJ20248B, DYNJ20252, DYNJ20335A, DYNJ20354A, DYNJ20355B, DYNJ20397A, DYNJ20405, DYNJ20409, DYNJ20422, DYNJ20425B, DYNJ20433, DYNJ20440A, DYNJ20441, DYNJ20442, DYNJ20462B, DYNJ20463, DYNJ20465B, DYNJ20466A, DYNJ20468B, DYNJ20472B, DYNJ20485B, DYNJ20487B, DYNJ20488B, DYNJ20489, DYNJ20489B, DYNJ20490A, DYNJ20491B, DYNJ20495B, DYNJ20496A, DYNJ20498A, DYNJ20498B, DYNJ20502B, DYNJ20503A, DYNJ20507A, DYNJ20508A, DYNJ20509B, DYNJ20518C, DYNJ20521A, DYNJ20522, DYNJ20522A, DYNJ20540B, DYNJ20567B, DYNJ20567B, DYNJ20609A, DYNJ20609B, DYNJ20639A, DYNJ20643A, DYNJ20696A, DYNJ20738, DYNJ20767B, DYNJ20775B, DYNJ20788B, DYNJ20789B, DYNJ20792, DYNJ20792, DYNJ20794, DYNJ20797A, DYNJ20806A, DYNJ20810, DYNJ20829A, DYNJ20834, DYNJ20838A, DYNJ20844A, DYNJ20846A, DYNJ20870, DYNJ20872A, DYNJ20888A, DYNJ20890A, DYNJ20891A, DYNJ20899, DYNJ20910, DYNJ20911A, DYNJ20913, DYNJ20928B, DYNJ20932B, DYNJ20933A, DYNJ20942A, DYNJ20955, DYNJ20994, DYNJ21003, DYNJ21011B, DYNJ21016, DYNJ21018, DYNJ21019A, DYNJ21020B, DYNJ21030, DYNJ21049A, DYNJ21063A, DYNJ21073B, DYNJ21088C, DYNJ21096, DYNJ21097, DYNJ21100A, DYNJ21123, DYNJ21140, DYNJ21149, DYNJ21149A, DYNJ21175A, DYNJ21183, DYNJ21187A, DYNJ21190, DYNJ21191, DYNJ21193, DYNJ21226, DYNJ21249, DYNJ21265, DYNJ21294A, DYNJ21296A, DYNJ21304, DYNJ21307A, DYNJ21307B, DYNJ21320, DYNJ21322, DYNJ21324B, DYNJ21327A, DYNJ21328B, DYNJ21329A, DYNJ21378, DYNJ21399A, DYNJ21400, DYNJ21404B, DYNJ21405A, DYNJ21406A, DYNJ21425, DYNJ21451A, DYNJ21452, DYNJ21475, DYNJ21476, DYNJ21484, DYNJ21485, DYNJ21491, DYNJ21494, DYNJ21497, DYNJ21497A, DYNJ21511, DYNJ21513, DYNJ21526, DYNJ21527, DYNJ21529, DYNJ21530, DYNJ21540, DYNJ21545, DYNJ21557, DYNJ21562, DYNJ21567, DYNJ21569, DYNJ21584, DYNJ21601, DYNJ21633, DYNJ21635, DYNJ21635A, DYNJ21677, DYNJ21718, DYNJ21721, DYNJ21722, DYNJ21726, DYNJ21728, DYNJ21736, DYNJ21737, DYNJ21739, DYNJ21777A, DYNJ21785, DYNJ21792A, DYNJ21797, DYNJ21798, DYNJ21803, DYNJ21804, DYNJ21805, DYNJ21817, DYNJ21818, DYNJ21826, DYNJ21827, DYNJ21828, DYNJ21839, DYNJ21886, DYNJ21965, DYNJ25096D, DYNJ25104D, DYNJ25167B, DYNJ25222B, DYNJ25229C, DYNJ25235C, DYNJ25240A, DYNJ25243A, DYNJ25270C, DYNJ25421A, DYNJ25458, DYNJ25461A, DYNJ25468C, DYNJ25538A, DYNJ25605B, DYNJ25624B, DYNJ25645B, DYNJ25715, DYNJ25757B, DYNJ25792A, DYNJ25795, DYNJ25796A, DYNJ25821A, DYNJ25825B, DYNJ25827A, DYNJ25829A, DYNJ25831B, DYNJ25891D, DYNJ25896B, DYNJ25896B, DYNJ25908, DYNJ25925, DYNJ25929, DYNJ25935A, DYNJ25936A, DYNJ25941A, DYNJ25957, DYNJ25987B, DYNJ26045A, DYNJ26045A, DYNJ26078A, DYNJ26100A, DYNJ26123A, DYNJ26171C, DYNJ26172C, DYNJ26178A, DYNJ26181A, DYNJ26189, DYNJ26190A, DYNJ26191A, DYNJ26192B, DYNJ26193B, DYNJ26196A, DYNJ26197, DYNJ26237A, DYNJ26241B, DYNJ26257B, DYNJ26260A, DYNJ26277, DYNJ26278, DYNJ26289, DYNJ26294, DYNJ26294, DYNJ26325, DYNJ26394A, DYNJ26420A, DYNJ26448, DYNJ26453A, DYNJ26455, DYNJ26459B, DYNJ26566, DYNJ26570, DYNJ26573, DYNJ26608, DYNJ26635A, DYNJ26685, DYNJ26724A, DYNJ26726, DYNJ26730, DYNJ26732, DYNJ26733A, DYNJ26750, DYNJ26753, DYNJ26757, DYNJ26761, DYNJ26764, DYNJ26776, DYNJ26786B, DYNJ26848, DYNJ26848A, DYNJ26849A, DYNJ26850, DYNJ26852, DYNJ26853, DYNJ26873, DYNJ26891, DYNJ26901, DYNJ26901A, DYNJ26922, DYNJ26937, DYNJ26956A, DYNJ26964, DYNJ26964A, DYNJ26988, DYNJ26993, DYNJ27055, DYNJ27073, DYNJ27088, DYNJ27110, DYNJ27154, DYNJ27154, DYNJ27160, DYNJ27165, DYNJ27173, DYNJ27234, DYNJ27273, DYNJ27278, DYNJ27309, DYNJ27313, DYNJ27315, DYNJ27337, DYNJ27412, DYNJ27438, DYNJC1028F, DYNJC1030G, DYNJC1131B, DYNJC1254J, DYNJC1267F, DYNJC1361G, DYNJC1382D, DYNJC1517D, DYNJC1520C, DYNJC1541G, DYNJC1542C, DYNJC1639G, DYNJC1657G, DYNJC1748B, DYNJC1753F, DYNJC1754A, DYNJC1834G, DYNJC1877A, DYNJC1910F, DYNJC1912C, DYNJC1916B, DYNJC1981F, DYNJC1986N, DYNJC2023I, DYNJC2202N, DYNJC2229L, DYNJC2237A, DYNJC2274G, DYNJC2281F, DYNJC2287B, DYNJC2288, DYNJC2338B, DYNJC2373B, DYNJC2375B, DYNJC2393A, DYNJC2399A, DYNJC2413B, DYNJC2414B, DYNJC2418, DYNJC2419G, DYNJC2420D, DYNJC2422B, DYNJC2427B, DYNJC2431G, DYNJC2431I, DYNJC2460A, DYNJC2484C, DYNJC2485, DYNJC2588D, DYNJC2606G, DYNJC2684D, DYNJC2701A, DYNJC2714A, DYNJC2715A, DYNJC2758J DYNJC2759I , DYNJC2760I, DYNJC2762J, DYNJC2763G, DYNJC2764G, DYNJC2766G, DYNJC2767I, DYNJC2768N, DYNJC2769I, DYNJC2794B, DYNJC2821, DYNJC2848C, DYNJC2915D, DYNJC2956D, DYNJC2985A, DYNJC2994D, DYNJC3091F, DYNJC3110C, DYNJC3117D, DYNJC3118G, DYNJC3137A, DYNJC3143G, DYNJC3184D, DYNJC3186C, DYNJC3187C, DYNJC3188D, DYNJC3191C, DYNJC3225C, DYNJC3256A, DYNJC3259B, DYNJC3276, DYNJC3279C, DYNJC3280B, DYNJC3292C, DYNJC3294A, DYNJC3299A DYNJC3304A, DYNJC3349C, DYNJC3360A, DYNJC3362A, DYNJC3367C, DYNJC3380A, DYNJC3417, DYNJC3418, DYNJH1054I, DYNJH1060B, DYNJH1158A, DYNJH1223C, DYNJH1227A, DYNJH1235F, DYNJH1236, DYNJHS0116F, DYNJHS0145A, DYNJHS0181C, DYNJHS0570, DYNJHS0597A, DYNJHS0597B, DYNJHS0604C, DYNJHS0605C, DYNJHS0628, DYNJHS0709B, DYNJQ0009A, DYNJQ0020A, DYNJQ0029D, DYNJQ0043, DYNJQ0059F, DYNJQ0060B, DYNJQ0063B, DYNJQ0064F, DYNJQ0097A, DYNJQ0100A, DYNJQ0114, DYNJQ0118B, DYNJQ0119B, DYNJQ0120A, DYNJQ0123A, DYNJQ0124B, DYNJQ0127, DYNJQ0128A, DYNJQ0131A, DYNJQ0140C, DYNJQ0157D, DYNJQ0162B, DYNJQ0171A, DYNJQ0172, DYNJQ0177A, DYNJQ0178C, DYNJQ0180B, DYNJQ0185A, DYNJQ0191F, DYNJQ0207, DYNJQ0221, DYNJQ0226C, DYNJQ0227B, DYNJQ0234A, DYNJQ0235A, DYNJQ0237A, DYNJQ0240A, DYNJQ0242A, DYNJQ0244B, DYNJQ0271, DYNJQ0286D, DYNJQ0299A, DYNJQ0301A, DYNJQ0304A, DYNJQ0306B, DYNJQ0308B, DYNJQ0320A, DYNJQ0338A, DYNJQ0365A, DYNJQ0369A, DYNJQ0370A, DYNJQ0376B, DYNJQ0405A, DYNJQ0411A, DYNJQ0415, DYNJQ0439B, DYNJQ0461A, DYNJQ0486, DYNJQ0497, DYNJQ0508, DYNJQ0526, DYNJQ0529, DYNJQ0541A, DYNJQ0543, DYNJQ0564, DYNJQ0567, DYNJQ0578, DYNJQ0584, DYNJSB0013, DYNJT0017G, DYNJT0018I, DYNJT0019I, DYNJT0055B, DYNJT0056A, DYNJT0087B, DYNJT0162D, DYNJT0225C, DYNJT0258A, DYNJT0483A, DYNJT0505B, DYNJT0507F, DYNJT0616B, DYNJT0617A, DYNJT0627G, DYNJT1076G, DYNJT1077J, DYNJT1081G, DYNJT1083F, DYNJT1084B, DYNJT1085G, DYNJT1107B, DYNJT1185C, DYNJT1187F, DYNJT1259B, DYNJT1273, DYNJT1282B, DYNJT1299B, DYNJT1302B, DYNJT1416F, DYNJT1459, DYNJT1485B, DYNJT1589A, DYNJT1678A, DYNJT1679C, DYNJT1695A, DYNJT1745F, DYNJT1759B, DYNJT1877B, DYNJT1878, DYNJT1901C, DYNJT1926B, DYNJT1927A, DYNJT1936, DYNJT1938, DYNJT1943A, DYNJT1945A, DYNJT1947, DYNJT1972D, DYNJT2003, DYNJT2014C, DYNJT2110B, DYNJT2119A, DYNJT2121B, DYNJT2144A, DYNJT2159C, DYNJT2179, DYNJT2180D, DYNJT2185A, DYNJT2248A, DYNJT2262, DYNJT2388A, DYNJT2432A, DYNJT2444, DYNJT2445, DYNJT2484C, DYNJV0039F, DYNJV0067I, DYNJV0069C, DYNJV0071G, DYNJV0073C, DYNJV0076A, DYNJV0078C, DYNJV0079D, DYNJV0083C, DYNJV0098B, DYNJV0100D, DYNJV0107F, DYNJV0160C, DYNJV0196B, DYNJV0218, DYNJY0001A, DYNJY0003A, DYNJY0010, DYNJY0019B, DYNJY0041B, DYNJY0042A, DYNJY0050B, DYNJY0056B, DYNJY0057C, DYNJY0059B, DYNJY0060C, DYNJY0064D, DYNJY0067C, DYNJY0069, DYNJY0074B, DYNJY0075A, DYNJY0080A, DYNJY0083B, DYNJY0085A, DYNJY0090, DYNJY0097A, DYNJY0098A, DYNJY0102A, DYNJY0110B, DYNJY0112A, DYNJY0118B, DYNJY0119, DYNJY0121, DYNJY0130A, DYNJY0131A, DYNJY0135, DYNJY0141A, DYNJY0144, DYNJY0150A, DYNJY0151A, DYNJY0152A, DYNJY0153, DYNJY0162B, DYNJY0166A, DYNJY0167A, DYNJY0168, DYNJY0169, DYNJY0173B, DYNJY0179B, DYNJY0181B, DYNJY0183B, DYNJY0184B, DYNJY0186A, DYNJY0195A, DYNJY0203C, DYNJY0207B, DYNJY0210, DYNJY0216, DYNJY0217A, DYNJY0218A, DYNJY0220, DYNJY0221, DYNJY0222, DYNJY0225, DYNJY0227, DYNJY0228, DYNJY0236, DYNJY0238A, DYNJY0239, DYNJY0240, DYNJY0241, DYNJY0244B, DYNJY0246, DYNJY0247, DYNJY0254A, DYNJY0276, DYNJY0277
Root Cause
Other
Action Taken
Field Correction letters dated 3/4/05 were sent to thedirect account hospitals on the same date to the attention of the manager of surgery, informing them of the potential indadequate side seal of the Tyvek breather pouches in the packs which may cause a compromise in the sterility of the product. The accounts were provided a list of the affected pack sent to the account and were requested to inspect any stocks of the affected product in stock, using the enclosed diagrams as an aid in the inspection for the defective side seals. Any defective product found should be returned to Medline. Any questions were directed to Lara Simmons, QA/RA Director at 1-800-879-2781, ext. 6072.